Clinical Research Gone Fully Mobile: Introducing TrialKit™

Electronic Data Capture (EDC) systems have changed considerably over the past several years. We can still remember the days when EDC systems were limited to the simplest of data collection, incapable of configuration. Today, modern systems are highly configurable and expedite the research process much more than paper studies ever could. But there has always been one limiting factor that prevented EDC systems from really helping clinical trial data management evolve: the web. Even with high speed internet, the complexity of front-end web interfaces cause slower interaction. Further, not all databases have what it takes to function with optimal performance without sacrificing capabilities. Another obstacle presented by these systems is that they may be intimidating to those who are inexperienced with electronic data capture.

Last year, we set out to change all of this – to do something truly unique that would have powerfully positive effects on clinical data collection and management. We overcame these obstacles by developing something that embraces today’s technology and appeals to future generations of researchers. From social media to retail, banking, and even education, everything has migrated to operating via native mobile apps. The healthcare industry should be no exception. With 2.32 billion smartphone users worldwide and a projected growth rate of roughly 24 percent by 2020, mobile technology is rapidly replacing its desktop predecessor.1

Enter TrialKit: a highly evolved and regulatory compliant mobile EDC system. With the support of Apple’s Special Projects team, we are excited to bring the next generation clinical trial platform to the Apple App Store®. TrialKit will be available exclusively on the App Store beginning April 2017.

What is TrialKit?
In short, it’s a native iOS app that frees clinical researchers from the constraints associated with a traditional EDC system; requiring no programming experience, the app empowers researchers with cleaner, more accessible data collection. Created using Apple’s Software Development Kit (XCode), TrialKit’s API service structure enables it to communicate with any other external database. The app has a modern skin and user interface, incorporating intuitive, familiar gestures which are commonly used on iPhones and iPads. Additionally, Apple’s HealthKit™ platform can be integrated directly into TrialKit, allowing health-centric iOS apps to communicate directly with the clinical trial database. Through increased patient engagement, fewer clinic visits, and decreased operating costs, the use of mobile devices reduces time to market and overall cost of clinical trials.

Lower cost and ease of use makes TrialKit available to more researchers than ever before. From a conveniently sized device, researchers can download a free app and build CRFs, design studies with better toolsets (including Apple’s HealthKit modules), deploy those studies around the globe, and manage the data as it comes in. When data collection is very time sensitive, it’s ideal to have a device within reach at all times. This is precisely what TrialKit offers to researchers. Study participants can also download TrialKit Patient™ to enter data for studies in which they are enrolled. In this way, it is truly a “kit” of study functionality that lends itself across the spectrum of users in a clinical trial.

Every part of a clinical trial life cycle can now be accomplished on devices that are sleeker, faster, and handier. Desktops and clunky browser-based applications are destined to become a tool of the past. Mobile devices can do so much more for clinical trials and data managers beyond what conventional EDC systems bring to the table. TrialKit for clinical research is the future, at the forefront of an industry-wide transformation that will play an important part in advancing medicine.

Why the name change?
Clinical Studio was designed for data managers to build and manage clinical research without the need for special programming skills or large learning curves. The term “Studio” reflected this well. Over the years, we’ve seen the equal importance and weight of every other user in the clinical trial life cycle – from the site coordinators to monitors, and especially the patients themselves. With those users in mind and the system’s newer patient-centric design, the name Clinical Studio no longer fit quite as well as it has in years past. Coupled with Apple’s HealthKit, the name TrialKit better encapsulates this wide gamut of capabilities.

How are TrialKit studies and Clinical Studio studies different?
TrialKit and Clinical Studio use the same database. Meaning, your login credentials are the same on both platforms and you will have access to the same studies on both platforms. The biggest differences between the two are in speed, performance, and accessibility. TrialKit has the upper-hand on all three!

What will happen to Clinical Studio on the web?
For now, nothing. Users who are more regularly on the website will not see any differences. Although, we highly recommend using TrialKit on an iPad or iPhone if at all possible – if for no other reason than a more modern user experience. Logging in on the TrialKit app will access the same database you see on the Clinical Studio website.

Moving forward, the team behind TrialKit will plan to update the web version for basic data entry, data management and a more modern user interface. This also will eventually be renamed TrialKit. As these changes approach, users will be notified but ultimately remain completely unaffected in their day-to-day work.